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Impact of a Family Information Leaflet on Effectiveness

of Information Provided to Family Members of Intensive


Care Unit Patients
A Multicenter, Prospective, Randomized, Controlled Trial
ELIE AZOULAY, FRÉDÉRIC POCHARD, SYLVIE CHEVRET, MERCÉ JOURDAIN, CAROLINE BORNSTAIN, ANNE WERNET,
ISABELLE CATTANEO, DJILALI ANNANE, FRÉDÉRIC BRUN, PIERRE-EDOUARD BOLLAERT, JEAN-RALPH ZAHAR,
DANY GOLDGRAN-TOLEDANO, CHRISTOPHE ADRIE, LUC-MARIE JOLY, JEROME TAYORO, THIBAUT DESMETTRE,
ETIENNE PIGNE, ANTOINE PARROT, OLIVIER SANCHEZ, CATHERINE POISSON, JEAN-ROGER LE GALL,
BENOÎT SCHLEMMER, and FRANÇOIS LEMAIRE for the French FAMIREA Group
Intensive Care and Biostatistics Departments of the Saint-Louis Teaching Hospital and Paris 7 University; Intensive Care Unit of the Cochin
Teaching Hospital, Paris; Intensive Care Unit of the Henri Mondor Teaching Hospital, Créteil, France; and the Ethics Committee of the French
Society for Critical Care

Comprehension and satisfaction are relevant criteria for evaluat- the patient if they are to participate in management decisions
ing the effectiveness of information provided to family members (6–8) and to speak for the patient. Moreover, good compre-
of intensive care unit (ICU) patients. We performed a prospective hension helps the family cope with the psychological stress as-
randomized trial in 34 French ICUs to compare comprehension of sociated with the ICU admission (1). Satisfaction of family
diagnosis, prognosis, treatment, and satisfaction with information members promotes favorable interactions with caregivers
provided by ICU caregivers, in ICU patient family representatives seeking to meet the needs of the family (2–5, 9). Previous
who did (n  87) or did not (n  88) receive a family information studies of the quality of information provided to family mem-
leaflet (FIL) in addition to standard information. An FIL designed
bers of ICU patients were mainly descriptive, although they
specifically for this study was delivered at the first visit of the fam-
also identified the determinants of comprehension and satis-
ily representative: it provided general information on the ICU and
faction in the family. Comprehension was associated with pa-
hospital, the name of the ICU physician caring for the patient, a
diagram of a typical ICU room with the names of all the devices,
tient’s age, delivery of a family information leaflet (FIL), and
and a glossary of 12 terms commonly used in ICUs. Characteristics caregivers’ perception of poor comprehension (1). Satisfaction
of the ICUs, patients, and family representatives were similar in was greater when the patient/nurse ratio was less than 3; when
the two groups. The FIL reduced the proportion of family mem- the family felt they received no contradictory information,
bers with poor comprehension from 40.9% to 11.5% (p  0.0001). knew the specific role of each caregiver, or were helped by
In the representatives with good comprehension, the FIL was asso- their usual physician; and when the interview time allowed to
ciated with significantly better satisfaction (21 [18 to 24, quartiles] the family increased. There are no published studies of the ef-
versus 27 [24 to 29, quartiles], p  0.01). These results indicate fects on comprehension and satisfaction of interventions de-
that ICU caregivers should consider using an FIL to improve the ef- signed specifically to improve the effectiveness of information
fectiveness of the information they impart to families. provided to families of ICU patients.
In previous studies, which were not randomized, handing
Keywords: family needs; satisfaction; comprehension; leaflet; informa- an information leaflet to the family members during the first
tion; intensive care interview improved comprehension (1), although the effect on
An important task for intensive care unit (ICU) physicians is satisfaction was inconsistent (2). These studies were con-
to provide family members with the appropriate, clear, and ducted each in a single ICU, in small numbers of families (1).
compassionate information they need to cope with their dis- Some used but did not evaluate the benefits of an information
tress and to participate in making decisions about patients leaflet (10, 11). Moreover, delivery of the information leaflet
who are unable to speak for themselves. Previous studies, to the family members was not strictly controlled in any of
from both the United States and Europe, have shown that the these studies (2, 12).
quality of information provided to family members of ICU pa- We sought to determine whether a standardized FIL im-
tients can be assessed based on two criteria, namely, compre- proved satisfaction and comprehension of the information
hension (1) and satisfaction with the information provided by provided to family members of ICU patients.
ICU caregivers to family members (2–5). Family members
METHODS
must understand the diagnosis, prognosis, and treatment in
Study Design
ICU selection. From a total of 114 French ICUs, members of the
(Received in original form August 29, 2001; accepted in final form October 12, 2001) French Society for Critical Care, we randomly selected 51 ICUs, strat-
Supported by a grant from the French Society for Critical Care. ifying on university versus community hospital and on the city (Paris
Correspondence and requests for reprints should be addressed to Élie Azoulay, area versus others). An invitation to participate in the study was sent
M.D., Service de réanimation médicale, Hôpital Saint-Louis, 1 avenue Claude to the heads of these 51 ICUs. A physician in each center (the investi-
Vellefaux 75010 Paris, France. E-mail: elie.azoulay@sls.ap-hop-paris.fr gator) collected ICU and patient characteristics on standardized forms.
This article has an online data supplement, which is accessible from this issue’s Inclusion criterion. The only eligibility criterion for each patient
table of contents online at www.atsjournals.org was the expected length of ICU stay, which was required to be at least
Am J Respir Crit Care Med Vol 165. pp 438–442, 2002 48 h. Each participating ICU included six consecutive patients meet-
DOI: 10.1164/rccm.200108-006OC ing this criterion, starting on July 1, 2000. The number of patients per
Internet address: www.atsjournals.org center was limited to six (including three with no FIL) because a
Azoulay, Pochard, Chevret, et al.: Family Information Leaflet 439

previous study showed that receiving an FIL had an independent fa- RESULTS
vorable effect on comprehension by family members of ICU patients
(1), and to avoid any center effect on study results. A total of 34 ICUs (442 beds) participated in the study and in-
Exclusion criteria. Patients were excluded from the study if (1) cluded a total of 204 patients (Figure 1). Eight patients died be-
they died within 48 h after ICU admission, (2) their family representa- fore their family members could be invited to complete the
tives refused to participate in the study, or (3) no family members vis- questionnaire, and 15 additional patients received no visits
ited them within 5 d after their admission to the ICU. within the first 5 d after ICU admission. This left 181 family rep-
Randomization procedure. Computer-generated random-number resentatives, of whom 175 (97%) accepted and 6 (3%) declined
tables were used to assign patients to the FIL or control group in to be interviewed about their comprehension and to complete
blocks of six stratified on ICU. Each participating ICU received six
the Critical Care Family Needs Inventory (CCFNI) question-
sealed envelopes, of which three contained an FIL and three a blank
sheet. To ensure full concealment of allocation, a biostatistics depart- naire. Thus, the study data were obtained from 175 family repre-
ment independent from the study ICUs carried out the randomization sentatives. A single ICU had two excluded patients (one in each
procedure, prepared the envelopes, and sent them to the study ICUs. randomized group); each of the other ICUs had one excluded
Consecutive patients whose length of stay in the ICU was expected to patient at the most. Randomization of the patients at admission
be longer than 48 h were randomized at admission. Family represen- assigned 88 family representatives to the FIL group and 87 to
tatives of control patients were informed according to routine practice the control group. The ICU physicians and nurses who collected
in the ICU before the study (“standard information,” including at the study data constitute the French FAMIREA group.
least one meeting with a physician each day during the first week of
ICU admission, with information on the diagnosis, prognosis, and Characteristics of the 34 ICUs
treatment). Family representatives in the FIL group received stan-
dard information and an FIL. At the first visit of the family represen-
As shown in Table 1, 17 (50%) ICUs were both medical and
tative to the ICU, an ICU caregiver other than the investigator surgical, 15 (44%) were medical, and two (6%) were surgical.
opened a sealed envelope and, if it contained an FIL, handed this doc- In 16 (47%) ICUs, it was standard practice for the physicians
ument to the family representative. Then, assessment of comprehen- and nurses to meet regularly to discuss family needs. Only in 6
sion (1) and satisfaction (see Appendix E1 in the online data supple- (18%) ICUs was information about a given patient provided
ment) (2, 3), and of anxiety and depression, were performed between by the same physician throughout the patient’s ICU stay.
the third and the fifth day. None of the collected parameters were significantly different
Further details on data collection, description of the standardized between the two randomized groups.
family information leaflet, and instruments used to measure the effec-
tiveness of information provided to family representatives can be Characteristics of the 175 Patients
found in the online data supplement.
Median age was 60 yr (range, 48 to 71) (Table 2). Thirty-nine
Statistical Analysis (22%) patients were not of French descent. Median Simplified
Results are expressed as quartiles. Comprehension in the two groups Acute Physiology Score (SAPS II) at admission was 41 (29 to
was compared using the chi-square test, or the Fisher exact test when 55), length of ICU stay was 9 (6 to 17) d, and in-ICU mortality
appropriate. Comparison of satisfaction in the two randomized groups was 25% (44 deaths). None of the collected parameters were
was performed using the nonparametric Mann-Whitney test. All p val- significantly different in the two randomized groups.
ues were two-sided, with values of 0.05 or less indicating statistical sig-
nificance. All statistical tests were done using the SAS 6.12 (SAS Inc., Characteristics of the 175 Family Members Who Completed
Cary, NC) package. the Questionnaires
Although 40 (23%) family members were not of French de-
Sample Size
scent (Table 3), all spoke French. Of the 175 family members,
Sample size was computed on the basis of previous results, suggesting 82 (47%) were spouses. The ratio of the time actually allowed
that the FIL would improve comprehension by approximately 20% to family members over the time they would have liked to
but would not influence satisfaction (1). To detect a 20% difference
spend receiving information was 0.66 (0.5 to 1), and the differ-
from a 50% noncomprehension rate without the FIL (i.e., 50% versus
30%), with a type I error of 0.05 and a power of 0.80, 204 patients had ence between the desired and actual times was 5 minutes (0 to
to be recruited, 102 in each group. 7.75). Twenty-nine (17%) family members reported receiving
contradictory information, 89 (51%) did not know the specific
role of each caregiver, 90 (51%) were not receiving help from
their usual doctor, and 68 (39%) expressed a desire to receive
help from a psychologist. One hundred sixty-five family mem-
bers (94%) were satisfied with the information provided by

TABLE 1. CHARACTERISTICS OF THE ICUs (n  34)

Number (%) or
Parameters Median (quartiles)

University hospital 15 (44.1)


Number of beds per unit 13 (7.25–16)
Waiting room available 27 (79.4)
Room for family information available 20 (58.8)
Number of attending physicians 3 (2–4)
Number of junior physicians 2 (1–3.75)
Nurse-to-patient ratio 3 (3–3.37)
Regular nurse–physician meetings about family information 16 (47)
Total daily visiting hours, min 120 (97–180)
Written protocol for interacting with families 4 (11.8)
FIL available (before the study) 26 (76.5)
Figure 1. Study profile. Information to each family always given by same physician 6 (17.6)
440 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL 165 2002

TABLE 2. CHARACTERISTICS OF PATIENTS (n  175)* tween the two groups. As shown in Table 4, comprehension
All Patients No Leaflet Leaflet
was significantly better in the FIL group (11.5 versus 41% of
Variable (n  175) (n  88) (n  87) p Value family members with poor satisfaction, p  0.0001).
Satisfaction did not differ significantly between the FIL
Age 60 (48–71) 61 (51–70) 57 (47–73) NS
and the control groups (median score, 21 [18 to 26] versus 23
Sex ratio, % women 62 (35.4) 30 (34) 32 (36.8) NS
Patients of French descent 136 (77.7) 68 (77.3) 68 (78.1) NS
[19 to 27], p  0.08). However, among family members with
Unmarried 32 (18.3) 12 (13.6) 20 (22.9) NS good comprehension, those who received the FIL had a signif-
Unemployed 31 (17.7) 16 (18.2) 15 (17.2) NS icantly better median satisfaction score than those who did not
Direct admission 43 (24.6) 21 (23.8) 22 (25.3) NS (21 [18 to 24] versus 27 [24 to 29], p  0.01) (Figure 2). Anxi-
ICU admission for ety and depression were not significantly less prevalent in the
Acute respiratory failure 99 (56.6) 48 (54.5) 51 (58.6) NS
FIL group. Moreover, the number of physician–family meet-
Shock 57 (32.6) 29 (32.9) 28 (32.2) NS
Acute renal failure 40 (22.8) 20 (22.7) 20 (23) NS
ings per patient was similar in the FIL group and in the control
Coma 66 (37.7) 31 (35.2) 35 (40.2) NS group (3 [2 to 5] versus 3 [1 to 4], respectively).
SAPS II 41 (29–55) 42 (30–55) 40 (27–54) NS
Length of ICU stay 9 (6–17) 10 (6–16) 9 (6–18) NS
ICU mortality rate 44 (25.1) 21 (23.9) 23 (26.4) NS
DISCUSSION
Definition of abbreviation: NS  not significant. Effective communication and a collaborative relationship be-
* Values are expressed as number (%) or median (ranges). tween ICU caregivers and their patients’ family members are
vital components of quality care (1–4, 9, 13, 14) and of compli-
ance with accreditation requirements (4). We report the first
junior physicians. According to the Hospital Anxiety and De- multicenter prospective randomized controlled study of an in-
pression Scale (HADS), 105 (60%) family members suffered tervention designed to improve the effectiveness of informa-
anxiety and 68 (39%) depression. None of these parameters tion provided by ICU caregivers to the family members of
was significantly different between the two randomized groups. their patients. A simple, easily produced leaflet significantly
improved comprehension by family members. Moreover, in
Comprehension and Satisfaction the subset of patients with good comprehension, the leaflet
Failure to comprehend the diagnosis, prognosis, or treatment improved satisfaction. This leaflet both provided information
was noted in 46 (26%) family members; 16 (9%) did not un- and extended an invitation to talk with ICU caregivers.
derstand the diagnosis, 18 (10%) the prognosis, and 37 (21%) Comprehension of and satisfaction with the information
the treatment. The median satisfaction score was 22 (19 to provided by ICU caregivers are essential if family members
26.5). Patients who understood the diagnosis, prognosis, and are to be not simply visitors to the ICU (13), but participants
treatment had a significantly lower CCFNI score, indicating in some of the aspects of the patient’s care and a source of in-
better satisfaction (21 [19 to 25] versus 25 [19 to 28], p  0.04). formation about the patient’s wishes (5, 12, 15).
Symptoms of anxiety and depression were associated neither Using our criterion of comprehension, about one-quarter
with comprehension nor with satisfaction. of the family members overall did not understand the diagno-
sis, prognosis, or treatment in the patient. This is only half the
Impact of the FIL on Comprehension and Satisfaction proportion in an earlier study (1), suggesting that efforts made
Tables 1–3 show that characteristics of the ICUs, the patients, in recent years to improve family management have met with
and the family members were not significantly different be- some success (10, 15–17). Analysis of comprehension assessed

TABLE 3. CHARACTERISTICS OF FAMILY REPRESENTATIVES*

All Representatives No Leaflet Leaflet p


Variable (n  175) (n  88) (n  87) Value

Age 49 (37–62) 50 (40–61) 46 (35–63) NS


Sex ratio, % women 49 (28) 23 (26.1) 26 (29.9) NS
Health care professionals 9 (5.1) 4 (4.5) 5 (5.7) NS
Family representatives of French descent 135 (77.1) 66 (75) 69 (79.3) NS
Relationship with the patient
Spouse 82 (46.8) 44 (50) 38 (43.7)
Parent 13 (7.4) 6 (6.8) 7 (8)
Child 49 (28) 25 (28.4) 24 (27.6) NS
Sibling 21 (12) 8 (9) 13 (14.9)
Other relatives 5 (2.8) 2 (2.3) 3 (3.5)
Not a relative 5 (2.8) 3 (3.4) 2 (2.3)
Hospital commuting time, min 30 (18–60) 45 (16–60) 30 (20–45) NS
Allowed/desired information time ratio 0.66 (0.5–1) 0.66 (0.5–1) 0.66 (0.5–1) NS
Representatives who felt they received contradictory information 29 (16.6) 17 (19.3) 12 (13.8) NS
Representatives who would have liked more information about
Diagnosis 113 (66.6) 61 (69.3) 52 (59.7)
Prognosis 110 (62.8) 56 (63.6) 54 (62) NS
Treatment 112 (64) 59 (67) 53 (60.9)
Representatives who did not know the specific role of each caregiver 89 (50.8) 51 (57.9) 38 (43.6) NS
Representatives not receiving help from their usual doctor 90 (51.4) 50 (56.8) 40 (45.9) NS
Representatives who would have liked help from a psychologist 68 (38.8) 36 (40.9) 32 (36.8) NS
Number of physician–family meetings between ICU admission and
comprehension assessment 3 (2–5) 3 (1–4) 3 (2–5) NS

* Values are expressed as number (%) or median (ranges).


Azoulay, Pochard, Chevret, et al.: Family Information Leaflet 441

TABLE 4. EVALUATION OF THE EFFECTIVENESS OF THE INFORMATION PROVIDED TO REPRESENTATIVES


OF ICU PATIENTS*

All Representatives No Leaflet Leaflet


(n  175) (n  88) (n  87) p Value

Poor comprehension 46 (26.3) 36 (40.9) 10 (11.5)  0.0001


Poor comprehension of the diagnosis 16 (9.1) 13 (14.7) 3 (3.4) 0.02
Poor comprehension of the prognosis 18 (10.3) 11 (12.5) 7 (8) 0.20
Poor comprehension of the treatment 37 (21.1) 31 (35.2) 6 (6.9)  0.0001
Satisfaction score (CCFNI)† 22 (19–26.5) 23 (19–27) 21 (18–26) 0.08

Definition of abbreviation: CCFNI  Critical Care Family Needs Inventory.


* Values are expressed as number (%) or median (ranges).

This score can range from 14 (extreme satisfaction) to 56 (extreme dissatisfaction) (5). Satisfactory comprehension of the diagnosis
was defined as knowledge of which organ was primarily involved in the disease process; satisfactory comprehension of the prognosis as
knowledge of whether the patient was expected to survive (not grave) or not (grave); and satisfactory comprehension of the treatment as
knowledge of at least one of the major treatments used among the list of 10 given by the physicians (1).

by the ICU investigators, who were blinded to group assign- (1, 11) who place meeting the needs of families among their
ment of family representatives, showed that the FIL reduced priorities (6, 15, 16, 20). However, one aspect of the leaflet
the proportion of patients with poor comprehension to ap- used in our study was an invitation to talk with ICU care-
proximately 11%. However, the leaflet improved the compre- givers. Talking more with the caregivers may provide opportu-
hension of diagnosis and treatment but not of prognosis, re- nities to obtain information in addition to that contained in an
flecting the focus of our leaflet on diagnosis and treatment, FIL, thereby improving comprehension. However, we found
and confirming previous reports that understanding the prog- no difference between the FIL and control groups regarding
nosis is difficult (18, 19). The prognosis is often more difficult the number of physician–family meetings. Our finding that the
to determine than the correct diagnosis and appropriate treat- FIL improved comprehension without providing information
ment, and this uncertainty may complicate the delivery of eas- specific to the patient is in agreement with the hypothesis that
ily understandable information on this point. The dichoto- efforts should be made upstream to the ICU to improve the
mous classification of the prognosis as “grave” or “not grave” general knowledge of family members about ICU operation
used to inform family members in our study can by no means and vocabulary. Information specific to the patient may be
be viewed as a basis for decision-making in the ICU, but may less likely to be grasped by family members.
help families to develop reasonable expectations and to set Good comprehension was associated with better satisfac-
their coping strategies in motion. tion. Although satisfaction was not significantly associated
In our study, the leaflet was used in combination with in- with delivery of the FIL, among patients with good compre-
formation imparted during face-to-face interviews. Conse- hension those who received the leaflet had significantly better
quently, our results should not be construed as meaning that satisfaction scores than those who did not. These data suggest
written information used alone can improve comprehension. two important interpretations. First, comprehension did not
The criterion for good comprehension used in this study has generate dissatisfaction: this runs counter to the hypothesis
been validated (1). It involves relatively limited knowledge of that poor satisfaction may be related to the seriousness of the
the patient’s condition. No criterion standard is available for patient’s condition in family members who would prefer to
assessing comprehension in family members of ICU patients. deny reality, i.e., to an unwillingness of the family to take in
We selected a criterion involving limited comprehension be- the information that is given to them. Second, comprehension
cause we believe that families cannot be expected to fully grasp is a foundation from which other benefits, such as better satis-
all the facets of the patient’s condition based only on informa- faction, can arise: family members with good comprehension
tion given during a brief period after ICU admission. are more likely to benefit from the efforts made by ICU care-
In the ICU, positive interaction between caregivers and givers to meet their needs.
family members requires an open exchange of information The prevalence of anxiety and depression in family mem-
aimed both at helping family members cope with their distress bers may be useful for evaluating the quality of information
and at allowing them to speak for the patient if necessary. Our provided by caregivers to family members of ICU patients.
findings indicate that an FIL improves this exchange of infor- We previously reported that both symptoms were common in
mation. Earlier data suggest that a leaflet may be perceived by family members (21). Nevertheless, the impact of these symp-
families as a message of welcome extended by ICU caregivers toms on the decision-making capacity of family members has
not been evaluated. The present study confirms the extremely
high rates of anxiety and depression in family members of
ICU patients. Above all, it demonstrates that anxiety and de-
Figure 2. Impact of the FIL pression measured 3 to 5 d after ICU admission are indepen-
on satisfaction in family mem- dent from comprehension and satisfaction. This strongly sug-
bers with good comprehen-
sion. CCFNI score ranged from
gests that family members experience anxiety and depression
14 (entire satisfaction) to 56 because the patient is in an ICU, not as a response to informa-
(entire dissatisfaction) (5). p  tion so painful that they cannot cope with it.
0.01 using the Mann-Whit- Meeting the needs of family members of ICU patients and
ney test.  Bad comprehen- improving their comprehension is of great importance for sev-
sion, no leaflet; bad com- eral reasons. First, more and more families are asking to par-
prehension, with leaflet;
good comprehension, no leaf-
ticipate in medical decisions (10, 17, 20). If caregivers and fam-
let;  good comprehension, ily members are to work together to determine what is best
with leaflet. for the patient, then the family members must have a reason-
able level of comprehension of the patient’s problem and be
442 AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE VOL 165 2002

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